On April 12, 2022 MediLink Therapeutics reported that YL201, the first compound based on MediLink’s proprietary antibody-drug conjugate (ADC) technology platform, has been cleared on its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for its Phase I first-in-human study (Press release, Medilink, APR 12, 2022, View Source [SID1234612103]).
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YL201 uses a novel "TMALIN" (Tumor Microenviroment Activable Linker) ADC technology developed at MediLink Therapeutics to resolve potential ADC resistance and stability issues. Preclinical data demonstrated great efficacy of YL201 in various in vivo tumor models, such as non-small cell lung cancer, prostate cancer and esophageal squamous cell carcinoma, and furthermore YL201 shows good tolerability in non-human primates. The clearance of our first IND marks an important milestone for MediLink and brings novel treatment opportunity of this conjugate drug to global cancer patients.